Trauma Organ Protection Using Artesunate (TOP-ART) 

Trial registration number: ISRCTN15731357

Artesunate is a drug that has been in use for many years as the treatment of choice for severe malaria. It has very few adverse effects and can even be used safely by patients with kidney failure or liver dysfunction.  

Using experimental (rat) models of severe bleeding, we have discovered that the intravenous injection of small doses of Artesunate (1 to 4.8 mg/kg) upon resuscitation reduces organ failure after trauma haemorrhage. The drug appears to enhance the protection of organs by reducing the body’s excessive inflammatory response to injury and blood loss, and by activating well-known cell-survival pathways. 

Having made this exciting discovery in the laboratory, C4TS now want to translate these findings to patients by conducting a Phase 2a clinical trial. 

The aim of this trial, ‘Trauma Organ Protection using ARTesunate’ (TOP-ART), is to compare safety and benefit of Artesunate administration in addition to standard treatment in severely-injured bleeding trauma patients.

Study Design

TOP-ART will be conducted as a single centre study at the Royal London Hospital Major Trauma Centre.  We will recruit 105 adult trauma patients who will be randomised to receive either:

  • Low dose intravenous Artesunate (35 patients)
  • High dose intravenous Artesunate (35 patients)
  • Placebo (35 patients)

The trial will enrol eligible patients over a 24-month period (starting early 2016) and determine patient outcomes in-hospital for up to 28 days and mortality at 90 days. The trial will start in the first quarter of 2017.

A therapeutic agent that reduces the incidence and severity of multiple organ failure could have a major global impact on trauma patient outcomes and their requirements for healthcare utilisation.

Key Documents

The key documents supporting the trial can be downloaded from the links below:

Study protocol

Consent form

Patient information sheet

Contacts

Principal Investigator: Professor Chris Thiemermann

Clinical Trial Manager: Ms Claire Rourke

 

Artesunate: ancient healer

Artesunate is a semi-synthetic derivative of the plant Artemisinin annua, also known as Sweet Wormwood.  The plant is found commonly in China where it has been used in Chinese herbal medicine for over 2000 years.

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